Systems and methods for bone stabilization and fixation

ABSTRACT

Systems for the minimally invasive repair, stabilization and/or fixation of a fractured bone, such as a rib, are disclosed. The systems include one or more rods/support members that are designed to extend along a dimension of a bone being repaired and secure the fractured bone. The support members can be photodynamic and are formed using an expandable member that is filled with a light-sensitive liquid that is cured to form the rigid support member. Two or more clamps are used to secure the support member(s) to the rib or other bone. Minimally invasive surgical methods for securing the systems to a fractured bone are also disclosed.

RELATED APPLICATIONS

This application is a continuation patent application of U.S.application Ser. No. 16/454,890, filed Jun. 27, 2019, which claims thebenefit of and priority to U.S. Provisional Application No. 62/690,765filed Jun. 27, 2018, the contents of each of which are herebyincorporated herein by reference in their entireties.

FIELD

The embodiments disclosed herein relate to bone stabilization systems,and more particularly to photodynamic devices for fixation of fracturedbones.

BACKGROUND

Bones form the skeleton of the body and allow the body to be supportedagainst gravity and to move and function in the world. Bone fracturescan occur, for example, from an outside force or from a controlledsurgical cut (an osteotomy).

Fractures to ribs or other bones are typically treated with platesand/or external fixation devices that involve a large incision andsignificant exposure. These plates and devices are typically secured tothe bone by screws or similar means that penetrate the inner cortex orintramedullary canal of the bone, and thereby compromise the integrityof the bone and can lead to infection and other secondary complications.It would be desirable to have an improved device and method forrepairing, stabilizing and/or fixating a fractured bone.

SUMMARY

Systems for repairing, stabilizing and/or fixating a fractured bone,such as a rib, and surgical methods for same. The systems may be usedfor temporary fixation, or permanent. The systems involve subcutaneousfixation, engaging the fractured bone through a patient's skin, butwithout penetrating the inner cortex or intramedullary canal of the rib(or other bone). The systems facilitate immediate stabilization of thefractured rib, while allowing normal chest wall motion duringinspiration/exhalation. Further, the system is adjustable to match apatient's anatomy and the fracture pattern/location. The surgical methodfor the system is simple, minimally invasive and does not require largeincisions.

The systems of the present disclosure include members that differ fromtraditional bone repair plates (e.g., for ribs) in that they are notpre-fabricated with a specific anatomical location, such as ribs on theright or left sides of the ribcage. Rather, the members of the disclosedsystem are agnostic to the right and left sides. Further, whiletraditional bone repair plates require adaptation to the anatomicalcurve of the patient, the systems of the present disclosure includemembers that are formed to contour to the shape and orientation of thespecific patient, thereby constituting a patient-customizedimplant/fixation system.

A device is provided for repairing a bone that includes an expandablemember and one or more clamps. The expandable member is capable ofmoving from a deflated state to an inflated state by infusing at leastone light sensitive liquid into the expandable member. The lightsensitive liquid is configured to cure within the expandable member toharden the expandable member. The one or more clamps are configured toengage a rib bone and receive the expandable member such that the one ormore clamps secure the expandable member to the rib bone. The inflationof the expandable member with the at least one light sensitive liquid isconfigured to be adjustable to conform to a shape of the rib bone.

In some embodiments, the device includes a delivery catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, the expandable member being releasably engaged withthe distal end of the delivery catheter.

In some embodiments, the one or more clamps include a posterior memberand an anterior member. In some embodiments, the posterior member andthe anterior member are movably connected to one another between an openposition such that the clamp is configured to be positioned on the ribbone and a closed positioned such that the clamp is configured to secureto at least a portion of the rib bone. In some embodiments, the one ormore clamps are shaped to receive the rib bone such that the one or moreclamps extend around at least a portion of the rib bone. In someembodiments, the one or more clamps include a posterior member and ananterior member, and the posterior includes first and second armsconfigured to extend around a portion of a posterior side of the ribbone to secure the one or more clamps thereto. In some embodiments, theone or more clamps include at least one contact point on a surface ofthe one or more clamps that is configured to contact the rib bone suchthat the at least one contact point is configured to increase the gripof the one or more clamps on the rib bone. In some embodiments, the oneor more clamps include first and second clamps positioned on either sideof a fracture in the rib bone.

In some embodiments, the expandable member is adjustable to conform tothe shape of the rib bone to allow for a correct orientation of the ribbone.

A device for repairing a bone is provided and includes an expandablemember releasably engaging a distal end of a delivery catheter having aninner lumen extending therethrough. One or more clamps are configured toengage a rib bone and receive the expandable member such that the one ormore clamps secure the expandable member to the rib bone. A light fibercan extend through the inner lumen into the expandable member to emit alight energy into the expandable member, and at least one reinforcingmaterial can be curable by the light energy emitted from the lightfiber. The expandable member is configured to move from a deflated stateto an inflated state when the at least one reinforcing material is addedinto the expandable member to allow for a correct orientation of the ribbone.

In some embodiments, the one or more clamps include a posterior memberand an anterior member. In some embodiments, the posterior member andthe anterior member are movably connected to one another between an openposition such that the clamp is configured to be positioned on the ribbone and a closed positioned such that the clamp is configured to secureto at least a portion of the rib bone. In some embodiments, the one ormore clamps are shaped to receive the rib bone such that the one or moreclamps extend around at least a portion of the rib bone. In someembodiments, the one or more clamps include at least one contact pointon a surface of the one or more clamps that is configured to contact therib bone such that the at least one contact point is configured toincrease the grip of the one or more clamps on the rib bone.

In some embodiments, the inflation of the expandable member with the atleast one reinforcing material is configured to be adjustable to allowthe expandable member to conform to a shape of the rib bone.

A method of repairing a fractured bone is provided and can includepositioning one or more clamps on a fractured rib bone. The one or moreclamps can include an opening configured to receive a portion of anexpandable member therethrough to secure the expandable member to thefractured rib bone. The expandable member, releasably engaging adelivery catheter, can be passed through the opening of the one or moreclamps, and the delivery catheter can have an inner void for passing ofa light sensitive liquid to the expandable member and an inner lumen forpassage of a light fiber to the expandable member. The expandable membercan be expanded by delivering the light sensitive liquid through thedelivery catheter and into the expandable member. The expansion of theexpandable member can be adjusted by altering the amount of the lightsensitive liquid therein to allow for correct orientation of the ribbone. The light fiber can be inserted through the delivery catheter andinto the expandable member to cure the light sensitive liquid within theexpandable member.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 is an anatomical cross-sectional view of a rib;

FIG. 2 shows a schematic illustration of an exemplary embodiment of abone repair system that includes a light source, a light pipe, anattachment system, a light-conducting fiber, a light-sensitive liquid, adelivery catheter and an expandable member;

FIG. 3A and FIG. 3B show close-up cross-sectional views of the regioncircled in FIG. 2. FIG. 3A shows a cross-sectional view of a distal endof the delivery catheter and the expandable member prior to the devicebeing infused with light-sensitive liquid. FIG. 3B shows across-sectional view of the distal end of the delivery catheter and theexpandable member after the device has been infused with light-sensitiveliquid and light energy from the light-conducting fiber is introducedinto the delivery catheter and inner lumen of the expandable member tocure the light-sensitive liquid;

FIG. 3C illustrates a side view of an embodiment of a distal end of thedelivery catheter and the expandable member of the present disclosure;

FIG. 4 illustrates an exemplary embodiment of an expandable member withone or more surface features;

FIG. 5A is a side sectional view of a clamp used in an embodiment of thepresent disclosure;

FIG. 5B illustrates the clamp shown in FIG. 5A, engaging a fracturedrib;

FIG. 6 illustrates an exemplary embodiment of a clamp having one or morepins on an anterior member thereof;

FIG. 7 illustrates a side view of an exemplary embodiment of clamp usedin a bone fixation system;

FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, and FIG. 8E illustrate exemplaryembodiments of a clamp used in a bone fixation system;

FIG. 8F illustrates the clamp of FIGS. 8A-8E positioned on a fracturedbone;

FIG. 8G illustrates the clamp of FIGS. 8A-8E positioned on a fracturedbone with an expandable member positioned therethrough;

FIG. 9 is a side sectional view of an exemplary embodiment of a clampused in a bone fixation system;

FIG. 10 is an exploded view of the clamp shown in FIG. 9;

FIG. 11A and FIG. 11B illustrate an exemplary embodiment of a clamp withgrips;

FIG. 12A, FIG. 12B, FIG. 12C, FIG. 12D, FIG. 12E, FIG. 12F, FIG. 12G,and FIG. 12H illustrate an embodiment of method steps for fixation of afractured rib; and

FIG. 13A and FIG. 13B illustrate an embodiment of a bone repair systemthat includes a plurality of expandable members.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Medical devices and methods for repairing bones are provided. Thedevices disclosed herein act as internal bone fixation devices and caninclude a delivery catheter terminating in a releasable expandablemember. During a procedure for repairing a fractured bone, such as a ribbone, the expandable member is placed along a length of a fractured bonein a deflated state. Once in place, the expandable member is expandedfrom a deflated state to an inflated state by the addition of at leastone light-sensitive material/reinforcing material. The at least onereinforcing material is subsequently hardened within the expandablemember using a light source. The hardened expandable member can bereleased from the delivery catheter and sealed to enclose the at leastone reinforcing material within the expandable member. The hardenedexpandable member remains along the fractured bone and can providesupport and proper orientation of the fractured bone resulting in therepair, healing, and strengthening of the fractured bone.

The term “bone” as used herein generally refers to elongated and flatbones. The bones include, without limitation, the ribs, the femur,tibia, and fibula of the leg, the humerus, radius, and ulna of the arm,metacarpals and metatarsals of the hands and feet, the phalanges of thefingers and toes, collar bone, the spanning or joining of the wrist, themandible, pelvis, and spine (i.e., vertebrae). The devices of thepresent disclosure are suitable for repairing various bones, includingthose listed above. In some embodiments, the devices are used in asurgical rib fixation procedure. In some embodiments, the devices areused in an external fixation procedure for bones. In some embodiments,the devices of the present disclosure are used to treat a fractured orweakened bone.

As used herein, the terms “fracture” or “fractured bone” refer to apartial or complete break in the continuity of a bone. The fracture canoccur, for example, from an outside force or from a controlled surgicalcut (osteotomy). The presently disclosed embodiments can be used totreat any type of bone fracture, including, but not limited to, adisplaced fracture, a non-displaced fracture, an open fracture, a closedfracture, a hairline fracture, a compound fracture, a simple fracture, amulti-fragment fracture, a comminuted fracture, an avulsion fracture, abuckle fracture, a compacted fracture, a stress fracture, a compressionfracture, spiral fracture, butterfly fracture, other fractures asdescribed by AO Foundation coding, multiple fractures in a bone, andother types of fractures.

As used herein, the term “weakened bone” refers to a bone with apropensity toward a fracture due to a decreased strength or stabilitydue to a disease or trauma. Some bone diseases that weaken the bonesinclude, but are not limited to, osteoporosis, achondroplasia, bonecancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, leggcalve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis,osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bonesare more susceptible to fracture, and treatment to prevent bonefractures may be desirable.

FIG. 1 is a cross-sectional illustration of a rib 1000, which includesanterior and posterior (i.e., front and back) surfaces 1002 and 1004,respectively, superior and inferior (i.e., top and bottom) surfaces1006, 1008, respectively, and a coastal groove 1010 formed in theposterior surface 1004 proximate the inferior surface 1008. The rib 1000has an outer portion comprising compact bone, and an inner portion(i.e., intramedullary canal) comprising bone marrow (i.e., hematopoietictissue).

The system of the present disclosure includes a photodynamic supportmember 102 (see FIG. 10G). In some embodiments, the photodynamic supportmember 102 is sufficiently designed to extend along a dimension of abone being repaired.

The photodynamic support member 102 is formed in any suitable manner.For example, as is described in detail below, the photodynamic supportmember 102 is formed by filling an expandable member 170, such as aballoon, with a photodynamic (light-curable) liquid 165 and exposing thephotodynamic (light-curable) liquid 165 to an appropriate frequency oflight and intensity to cure the photodynamic liquid 165 inside theexpandable member 170 to form a rigid structure that extends along abone to be repaired, such as a fractured rib (see FIG. 3A and FIG. 3B).

FIG. 2 in conjunction with FIG. 3A, FIG. 3B and FIG. 3C show schematicillustrations of an embodiment of a bone implant system 100 forformation and implantation of the photodynamic support member 102. Insome embodiments, the system 100 includes a light source 110, a lightpipe 120, an attachment system 130 and a light-conducting fiber 140. Theattachment system 130 communicates light energy from the light source110 to the light-conducting fiber 140. In some embodiments, the lightsource 110 emits frequency that corresponds to a band in the vicinity of390 nm to 770 nm, the visible spectrum. In some embodiments, the lightsource 110 emits frequency that corresponds to a band in the vicinity of410 nm to 500 nm. In some embodiments, the light source 110 emitsfrequency that corresponds to a band in the vicinity of 430 nm to 450nm. The system 100 further includes a flexible delivery catheter 150having a proximal end that includes at least two ports and a distal endterminating in an expandable member 170 (e.g., a balloon). In someembodiments, the expandable member 170 is manufactured from anon-compliant (non-stretch/non-expansion) conformable material. In someembodiments, the expandable member 170 is manufactured from aconformable compliant material that is limited in dimensional change byembedded fibers. Optionally, in some embodiments, one or more radiopaquemarkers, bands or beads can be placed at various locations along theexpandable member 170 and/or the flexible delivery catheter 150 so thatcomponents of the system 100 can be viewed using fluoroscopy.

In some embodiments, the system 100 includes one or more ports. In theembodiment shown in FIG. 2, a proximal end of the catheter 150 includestwo ports. One of the ports can accept, for example, thelight-conducting fiber 140. The other port can accept, for example, asyringe 160 housing a light-sensitive liquid 165. In some embodiments,the syringe 160 maintains a low pressure during the infusion andaspiration of the light-sensitive liquid 165. In some embodiments, thesyringe 160 maintains a low pressure of about 10 atmospheres or lessduring the infusion and aspiration of the light-sensitive liquid 165. Insome embodiments, the light-sensitive liquid 165 is a photodynamic(light-curable) monomer. In some embodiments, the photodynamic(light-curable) monomer is exposed to an appropriate frequency of lightand intensity to cure the monomer inside the expandable member 170 andform a rigid structure. In some embodiments, the photodynamic(light-curable) monomer 165 is exposed to electromagnetic spectrum thatis visible (frequency that corresponds to a band in the vicinity of 390nm to 770 nm). In some embodiments, the photodynamic (light-curable)monomer 165 is radiolucent, which permit x-rays to pass through thephotodynamic (light-curable) monomer 165.

As illustrated in FIG. 3A and FIG. 3B, the flexible delivery catheter150 includes an inner void 152 for passage of the light-sensitive liquid165, and an inner lumen 154 for passage of the light-conducting fiber140. In the embodiment illustrated, the inner lumen 154 and the innervoid 152 are concentric to one another. The light-sensitive liquid 165has a low viscosity or low resistance to flow, to facilitate thedelivery of the light-sensitive liquid 165 through the inner void 152.In some embodiments, the light-sensitive liquid 165 has a viscosity ofabout 1000 cP or less. In some embodiments, the light-sensitive liquid165 has a viscosity ranging from about 650 cP to about 450 cP. Theexpandable member 170 may be inflated, trial fit and adjusted as manytimes as a user wants with the light-sensitive liquid 165, up until thelight source 110 is activated, when the polymerization process isinitiated. Because the light-sensitive liquid 165 has a liquidconsistency and is viscous, the light-sensitive liquid 165 may bedelivered using low pressure delivery and high-pressure delivery is notrequired but may be used.

In reference to FIG. 3C, in some embodiments, the expandable member 170can include an inner lumen in fluid connection with the inner lumen 154of the delivery catheter 150. In this manner, the light conducting fiber140 can be passed into the expandable member 170. The inner lumen 153 ofthe expandable member 170 may be an extension of the inner lumen 154 ofthe delivery catheter or may be a separate tube in fluid communicationwith the inner lumen 154 of the delivery catheter.

Light Cured Materials (LCMs) utilize energy provided by light, forexample ultraviolet (UV) or visible light, to cure. Being veryenergetic, UV light can break chemical bonds, making molecules unusuallyreactive or ionizing them, in general changing their mutual behavior. Inan embodiment, a light emitted by a light source reacts with aphotoinitiator sensitive to UV light or visible light. Photoinitiatorsprovide important curing mechanisms for addition polymerization.

Using a UV light, the reinforcing material ensures there is no orminimal thermal egress and that the thermal egress may not be long induration. More specifically, there is no chemical composition or mixingof materials. The introduction of light starts the photoinitiator andthe glue hardens. Once the light is introduced, the material inside theballoon hardens and the materials inside are affixed in place. Until thelight is introduced, the bone placement is not disturbed or rushed asthere is no hardening of a glue until the light is introduced, theballoon may be inflated or deflated due to the viscosity of the glue.The glue can be infused or removed from the balloon due to the lowviscosity of the material. In some embodiments, the viscosity of thereinforcing material is less than approximately 1000 cP. Not allembodiments are intended to be limited in this respect and someembodiments may include reinforcing materials having a viscosity exactlyequal to or greater than 1000 cP.

Different light cured materials use photoinitiators sensitive todifferent ranges of UV and visible light. For example, visible bluelight may be useful to the curing process as it allows materials to becured between substrates that block UV light but transmit visible light(e.g., plastics). Visible light increases the cure speed of light curedmaterials since a greater portion of the electromagnetic spectrum isavailable as useful energy. Further, visible light penetrates throughlight cured materials to a greater depth-enhancing cure depth. The lightcured materials cure in such a way that is sufficient to hold a bone inthe correct orientation. More specifically, the ability to inflate, set,adjust, orient bones, and the resulting union of the bone are availableprior to hardening the glue.

In some embodiments, a contrast material can be added to thelight-sensitive liquid 165 without significantly increasing theviscosity. Contrast materials include, but are not limited to, bariumsulfate, tantalum, or other contrast materials known in the art. Thelight-sensitive liquid 165 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner void 152of the flexible delivery catheter 150 up into an inner cavity 172 of theexpandable member 170 to change a thickness of the expandable member 170without changing a width or depth of the expandable member 170. In someembodiments, the light-sensitive liquid 165 is delivered under lowpressure via the syringe 160 attached to the port. The light-sensitiveliquid 165 can be aspirated and reinfused as necessary, allowing forthickness adjustments to the expandable member 170 prior to activatingthe light source 110 and converting the liquid monomer 165 into a hardpolymer.

In some embodiments, the light-sensitive liquid can be provided as aunit dose. As used herein, the term “unit dose” is intended to mean aneffective amount of light-sensitive liquid adequate for a singlesession. By way of a non-limiting example, a unit dose of alight-sensitive liquid of the present disclosure for expanding theexpandable member 170 may be defined as enough light-sensitive liquid toexpand the expandable member 170 to a desired shape and size. Thedesired shape and size of the expandable member 170 may vary somewhatfrom patient to patient. Thus, a user using a unit dose may have excesslight-sensitive liquid left over. It is desirable to provide sufficientamount of light-sensitive liquid to accommodate even the above-averagepatient. In some embodiments, a unit dose of a light-sensitive liquid ofthe present disclosure is contained within a container. In someembodiments, a unit dose of a light-sensitive liquid of the presentdisclosure is contained in an ampoule. In some embodiments, theexpandable member 170 is sufficiently shaped and sized to extend along adimension (e.g., the length) of a fractured bone, or at least portionthereof. In some embodiments, the light-sensitive liquid can bedelivered under low pressure via a standard syringe attached to theport.

As illustrated in FIG. 2 in conjunction with FIG. 3B, thelight-conducting fiber 140 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner lumen 154of the flexible delivery catheter 150 up into the expandable member 170.The light-conducting fiber 140 is used in accordance to communicateenergy in the form of light from the light source to the remotelocation. The light-sensitive liquid 165 remains a liquid monomer untilactivated by the light-conducting fiber 140 (cures on demand). Radiantenergy from the light source 110 is absorbed and converted to chemicalenergy to polymerize the monomer. The light-sensitive liquid 165, onceexposed to the correct frequency light and intensity, is converted intoa hard polymer, resulting in a rigid structure or photodynamic supportmember of the present disclosure. In some embodiments, the monomer 165cures in about five seconds to about five minutes. This cure affixes theexpandable member 170 in an expanded shape to form a photodynamicimplant of the present disclosure. A cure may refer to any chemical,physical, and/or mechanical transformation that allows a composition toprogress from a form (e.g., flowable form) that allows it to bedelivered through the inner void 152 in the flexible delivery catheter150, into a more permanent (e.g., cured) form for final use in vivo. Forexample, “curable” may refer to uncured light-sensitive liquid 165,having the potential to be cured in vivo (as by catalysis or theapplication of a suitable energy source), as well as to alight-sensitive liquid 165 in the process of curing (e.g., a compositionformed at the time of delivery by the concurrent mixing of a pluralityof composition components). The inner lumen of the delivery catheter canengage the expandable member for permitting a light fiber to extendthrough the inner lumen into the expandable member to guide light energyinto the expandable member to cure at least one light sensitive liquid,or reinforcing material, curable by the light energy while minimizingthermal egress of the light energy to surrounding tissue from theexpandable member.

Light-conducting fibers use a construction of concentric layers foroptical and mechanical advantages. The light-conducting fiber can bemade from any material, such as glass, silicon, silica glass, quartz,sapphire, plastic, combinations of materials, or any other material, andmay have any diameter, as not all embodiments of the present disclosureare intended to be limited in this respect. In some embodiments, thelight-conducting fiber is made from a polymethyl methacrylate core witha transparent polymer cladding. The light-conducting fiber can have adiameter between approximately 0.75 mm and approximately 2.0 mm. In someembodiments, the light-conducting fiber can have a diameter of about0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mmor greater than about 2 mm as not all embodiments of the presentdisclosure are intended to be limited in this respect. In someembodiments, the light-conducting fiber is made from a polymethylmethacrylate core with a transparent polymer cladding. It should beappreciated that the above-described characteristics and properties ofthe light-conducting fibers are exemplary and not all embodiments of thepresent disclosure are intended to be limited in these respects. Lightenergy from a visible emitting light source can be transmitted by thelight-conducting fiber. Various wavelengths of light can be to cure theliquid inside the expandable member. In some embodiments, visible lighthaving a wavelength spectrum of between about 380 nm to about 780 nm,between about 400 nm to about 600 nm, between about 420 nm to about 500nm, between about 430 nm to about 440 nm, is used to cure thelight-sensitive liquid.

The most basic function of a fiber is to guide light, i.e., to keeplight concentrated over longer propagation distances—despite the naturaltendency of light beams to diverge, and possibly even under conditionsof strong bending. In the simple case of a step-index fiber, thisguidance is achieved by creating a region with increased refractiveindex around the fiber axis, called the fiber core, which is surroundedby the cladding. The cladding may be protected with a polymer coating.Light is kept in the “core” of the light-conducting fiber by totalinternal reflection. Cladding keeps light traveling down the length ofthe fiber to a destination. In some instances, it is desirable toconduct electromagnetic waves along a single guide and extract lightalong a given length of the guide's distal end rather than only at theguide's terminating face.

In some embodiments, at least a portion of a length of alight-conducting fiber is modified, e.g., by removing the cladding, inorder to alter the profile of light exuded from the light-conductingfiber. The term “profile of light” refers to, without limitation,direction, propagation, amount, intensity, angle of incidence,uniformity, distribution of light and combinations thereof. In someembodiments, the light-conducting fiber emits light radially in auniform manner, such as, for example, with uniform intensity, along alength of the light-conducting fiber in addition to or instead ofemitting light from its terminal end/tip. To that end, all or part ofthe cladding along the length of the light-conducting fiber may beremoved. It should be noted that the term “removing cladding” includestaking away the cladding entirely to expose the light-conducting fiberas well as reducing the thickness of the cladding. In addition, the term“removing cladding” includes forming an opening, such as a cut, a notch,or a hole, through the cladding. In some embodiments, removing all orpart of the cladding can alter the propagation of light along thelight-conducting fiber. In some embodiments, removing all or part of thecladding can alter the direction and angle of incidence of light exudedfrom the light-conducting fiber.

The cladding can be removed using a variety of techniques. In someembodiments, the cladding is removed by making a plurality of cuts inthe cladding to expose the core of the light-conducting fiber. In someembodiments, the cladding is removed in a spiral fashion. In someembodiments, the cladding is removed in such a way that a similar amountof light is exuded along the length of the modified section of thelight-conducting fiber. In some embodiments, the cladding is removed insuch a way that the amount of light exuded along the length of themodified section of the light-conducting fiber changes from the distalend to the proximal end of the modified section. In some embodiments,the cladding is removed in such a way that the amount of light exudedalong the modified section of the light-conducting fiber decreases fromthe distal end of the modified section of the light-conducting fibertoward the proximal end thereof. In some embodiments, to alter theprofile of the light exuded from the modified section, the cuts in thecladding are located along the length of the fiber in a spiral. In someembodiments, the pitch or spacing between the cuts is varied along thelength of the modified section of the light-conducting fiber. In someembodiments, the spacing between the cuts increases from the proximalend of the modified section of the light-conducting fiber 165 to thedistal end thereof such that the amount of light exuded from themodified section of the light-conducting fiber progressively increasestoward the distal end of the modified section of the light-conductingfiber.

In some embodiments, the light conducting fiber 140 is part of thedelivery catheter 150 or separately placed in the delivery catheter 150.In some embodiments, the light conducting fiber 140 is part of theexpandable member 170, or the light conducting fiber 140 is a separatecomponent that is placed in the expandable member 170 before or afterthe expandable member 170 is secured to the bone.

The size and shape of the expandable member 170 can vary and candetermined by a variety of factors, including but not limited to theanatomy of the bone to be repaired, characteristics of the fracture orother injury to the bone, or both. Suitable shapes include, but are notlimited to, tubular, round, flat, cylindrical, dog bone, barbell,tapered, oval, conical, spherical, square, rectangular, toroidal andcombinations thereof. In some embodiments, the expandable member 170 istubular or cone shaped having a substantially centerline openingextending for a length of the expandable member. In some embodiments,the expandable member 170 has a diameter of 8 mm or smaller. In variousembodiments, the expandable member 170 has a length of 60 mm, 80 mm, 100mm, 120 mm, 140 mm, 160 mm, 180 mm, 200 mm or 220 mm. In someembodiments, the expandable member 170 can be longer than necessary torepair the fracture rib, and any excess material can be cut off of thephotodynamic support member 102 after it has been formed by (i.e., aftercuring the light-sensitive liquid 165 infused into the expandable member170).

The materials forming the expandable member can also vary and have avariety of features. In some embodiments, the external surface of theexpandable member 170 is resilient and puncture resistant. Theexpandable member 170 can be manufactured from a non-compliant(non-stretch/non-expansion) conformable material including, but notlimited to urethane, polyethylene terephthalate (PET), nylon elastomerand other similar polymers. In some embodiments, the expandable member170 is manufactured from a polyethylene terephthalate (PET). In someembodiments, the expandable member 170 is manufactured from aradiolucent material, which permit x-rays to pass through the expandablemember 170. In some embodiments, the expandable member 170 ismanufactured from a radiolucent polyethylene terephthalate (PET). Insome embodiments, the expandable member 170 is manufactured from aconformable compliant material that is limited in dimensional change byembedded fibers. In some embodiments, at least a portion of the externalsurface of the expandable member 170 is substantially even and smooth.

Optionally, the expandable member can include surface features on anouter surface of the expandable member. FIG. 4 illustrates an exemplaryembodiment of an expandable member 180 with one or more surface features182 on a surface thereof. The surface features can take a variety offorms. In some embodiments, at least a portion of the external surfaceof the expandable member 170 includes at least one textured element suchas a bump, a ridge, a rib, an indentation or any other shape. In someembodiments, at least a portion of the external surface of theexpandable member 170 protrudes out to form a textured element. In someembodiments, at least a portion of the external surface of theexpandable member 170 invaginates to form a textured element. In someembodiments, the textured element increases the friction and improvesthe grip and stability of the expandable member 170 after the expandablemember 170 is positioned on and affixed to the bone by the fracturelocation. In some embodiments, the textured element results in increasedinterdigitation of bone-device interface as compared to an expandablemember without textured elements. In some embodiments, the texturedelement can be convex in shape. In some embodiments, the texturedelement can be concave in shape. In some embodiments, the texturedelement can be circumferential around the width of the expandable member170, either completely or partially.

In some embodiments, the expandable member 170 can include an externalsurface that may be coated with materials including, but not limited to,drugs (for example, antibiotics), proteins (for example, growth factors)or other natural or synthetic additives (for example, radiopaque orultrasonically active materials). For example, after a surgicalprocedure an infection may develop in a patient, requiring the patientto undergo antibiotic treatment. An antibiotic drug may be added to theexternal surface of the expandable member 170 to prevent or combat apossible infection. Proteins, such as, for example, bone morphogenicprotein or other growth factors have been shown to induce the formationof cartilage and bone. A growth factor can be added to the externalsurface of the expandable member 170 to help induce the formation of newbone. Due to the lack of thermal egress of the light-sensitive liquid165 in the expandable member 170, the effectiveness and stability of thecoating is maintained.

In some embodiments, the expandable member 170 is free of any valves.One benefit of having no valves is that the expandable member 170 can beexpanded or reduced in size as many times as necessary to assist in thefracture reduction and placement. Another benefit of the expandablemember 170 having no valves is the efficacy and safety of the system100. Since there is no communication passage of light-sensitive liquid165 to the body there cannot be any leakage of the light-sensitiveliquid 165 because all the light-sensitive liquid 165 is containedwithin the expandable member 170. In some embodiments, a permanent sealis created between the expandable member 170 and the delivery catheter150 that is both hardened and affixed prior to the delivery catheter 150being removed.

In some embodiments, abrasively treating the external surface of theexpandable member 170, for example, by chemical etching or air propelledabrasive media, improves the connection and adhesion between theexternal surface of the expandable member 170 and a bone surface. Thesurfacing significantly increases the amount of surface area that comesin contact with the bone which can result in a stronger grip.

The expandable member 170 can be infused with light-sensitive liquid 165and the light-sensitive liquid 165 can be cured to form a photodynamicsupport member 102, which can then be separated from the deliverycatheter 150.

In some embodiments, a separation area is located at the junctionbetween the distal end of the expandable member 170 and the deliverycatheter 150 to facilitate the release of the photodynamic supportmember 102 from the delivery catheter 150. The separation area ensuresthat there are no leaks of reinforcing material from the elongated shaftof the delivery catheter and/or the photodynamic support member 102. Theseparation area seals the photodynamic support member 102 and removesthe elongated shaft of the delivery catheter by making a break at aknown or predetermined site (e.g., a separation area). The separationarea may be various lengths and up to about an inch long. The separationarea may also have a stress concentrator, such as a notch, groove,channel or similar structure that concentrates stress in the separationarea. The stress concentrator can also be an area of reduced radialcross section of cured light-sensitive liquid inside a contiguouscross-sectional catheter to facilitate separation by the application oflongitudinal force. The stress concentrator is designed to ensure thatthe photodynamic support member 102 is separated from the deliverycatheter 150 at the separation area. When tension is applied to thedelivery catheter 150, the photodynamic support member 102 separatesfrom the shaft of the delivery catheter 150, substantially at thelocation of the stress concentrator. The tension creates a sufficientmechanical force to preferentially break the cured material and cathetercomposite and create a clean separation of the photodynamicimplant/shaft interface. It should of course be understood that thephotodynamic support member 102 may be separated from the deliverycatheter 150 by any other means known and used in the art, includingradial twisting, shear impact, and cross-sectional cutting.

In some embodiments, the shape of the photodynamic support member 102generally corresponds to the shape of the expandable member 170.Modification of light-sensitive liquid 165 infusion allows a user toadjust the span or thickness of the expandable member 170 to providespecific photodynamic support member 102 size and shape to each subject.In that the expandable member 170 is formable and shapeable by the userprior to the photocuring of the light-sensitive liquid 165 in theexpandable member 170, the photodynamic support member 102 best mirrorsthe size and shape of the area (i.e., of the rib 1000 or other bone tobe repaired) onto which it is affixed. In some embodiments, the size andshape of the final photodynamic support member attempts to maximize thesurface contact area with the bone, minimizing specific points ofconcentrated pressure. In some embodiments, the size and shape of thephotodynamic support member 102 attempts to maximize the surface contactarea with the bone, minimizing specific points of concentrated pressure.

The photodynamic support member 102 is secured to the rib 1000 by one ormore clamps that are configured to receive the expandable member 170, asfurther discussed below.

FIG. 5A illustrates an embodiment of a clamp, or clip, 200 that can beused to receive an expandable member and secure the expandable member toa bone, such as a rib bone. FIG. 5B illustrates an embodiment of theclamp 200 affixed to a fractured rib 1000 in accordance with the systemof the present disclosure. The clamp 200 is designed tocircumferentially engage the rib 1000 via an interference fit and/orcompression fit.

In some embodiments, the clamp 200 is constructed of one piece ofmaterial. In other embodiments, the clamp 200 is formed from two or morepieces of material. In various embodiments, the material(s) is anybiologically acceptable material, including, without limitation, aceramic, plastic (polymer), metal or alloy. Suitable plastics/polymersinclude polyether ether ketone (PEEK), ultra-high molecular weightpolyethylene (UHMW-PE), polypropylene (PP), polyethylene (PE) andpolymethylmetacrylate (PMMA). Suitable metals and metal alloys include,but are not limited to, Nb, Zr, Ti, Ta, Co, V, Cr, Al, alloys thereof,stainless steel, cobalt chrome and combinations thereof. Suitableceramic materials include, but are not limited to, alumina, zirconia,chromium carbide, chromium nitride, silicon carbide, silicon nitride,titanium carbide, zirconium carbide, zirconium nitride, tantalumcarbide, tungsten carbide, and any combination thereof.

In some embodiments, the clamp 200 is made from a radiolucent material,in order to eliminate scatter or other artifacts created duringradiographic imaging of the rib or other bones (e.g., via x-ray, MRI, CTscan, etc.).

In some embodiments, the clamp 200 is configured to be placed on theanterior surface 1002 of the rib 1000. In some embodiments, the clamp200 is configured to engage the posterior surface 1004 and/or the costalgroove 1010 of the rib 1000.

As illustrated in FIG. 5A and FIG. 5B, the clamp 200 includes a plate,or base, 210 having an anterior surface 210 a and a posterior surface210 b that is configured to lie along the anterior surface 1002 of therib 1000. In some embodiments, the posterior surface 210 b is formedfrom or lined with a soft material that is compressive (i.e., allows forsurface compression) and thereby enhances contact with the anteriorsurface 1002 of the rib 1000 and increases stability.

A ring member 212 extends outwardly from the anterior surface 210 a ofthe plate 210 and defines an opening 214. The ring member 212 andopening 214 are sized to receive the expandable member 170 therein, asfurther discussed below.

The clamp 200 further includes an anterior member 216 and a posteriormember 218 that cooperate to enclose the rib 1000, plate 210 and ringmember 212 therein. In some embodiments, the anterior member 216includes two arcuate members 216 a, 216 b, which are arranged on eitherside of the ring member 212. This configuration and other configurationsof the clamp 200 facilitate more significant engagement with/on thesuperior surface 1006/posterior surface 1004 of the rib 1000, to protectthe blood vessels and nerves that are close to/run along the inferiorsurface 1008 of the rib 1000 (e.g., blood vessels within the costalgroove 1010) by minimizing contact with these blood vessels and nerves.

The anterior and posterior members 216, 218 cooperate to form a topportion 220 of the clamp 200 and a bottom portion 222 of the clamp 200.The top portion 220 is configured to engage the superior surface 1006 ofthe rib 1000, while the bottom portion 222 is configured to engage thecostal groove 1010 and inferior surface 1008 of the rib 1000.

In some embodiments, the anterior and posterior members 216, 218 arerotatably and/or pivotally connected to each other to allow the topportion 220 of the clamp 200 to rotate or pivot relative to the bottomportion of the clamp 200. Any suitable connection between the topportion and the bottom portion can be used to achieve this relativemotion, such as with one or more hinges or pivot points (not shown). Insome embodiments, the anterior and posterior members 216, 218 arereleaseably connected to each other to form the bottom portion 222. Anymethods of attachment known in the art and suitable for attachingmedical device components can be utilized. The anterior and posteriormembers 216, 218 can include various fasteners to releaseably connect toeach other, including, but not limited to, clips, pins, cooperatingserrated teeth/slots, hinges and one or more screws. In someembodiments, a screw assembly with a radial dial having a varied taperedwedge (not shown) can be used that can be rotated to draw the anteriorand posterior members 216, 218 closer to each other. In someembodiments, the anterior and posterior members 216, 218 are affixed toeach other via a spring-loaded connection. In some embodiments, theclamp 200 includes a cam action bar (not shown) operably attached to theanterior and posterior members 216, 218, by which clamp 200 can besecured to the rib 1000, and by which the expandable member 170 can besecured (i.e., locked) within the opening 214 of the ring member 212.

In some embodiments, at least the bottom portion 222 of the clamp 200has a low profile, to avoid contact and/or interference with nearbyanatomical structures, including the nerve residing within the costalgroove and nearby blood vessels (i.e., arteries and veins). In someembodiments, the entire clamp 200 has a low profile, so as to be asclose to the rib 1000 as possible.

In some embodiments, the photodynamic support member 102 is securedunder the anterior member 216 under implant 102. The plate 210 caninclude one or more contact points, or pins 224, that can contact therib 1000, as shown in FIG. 6, whereby deflection of the anterior member216 pushes against the rib 1000 to reinforce the fixation of the clamp200 to the rib 1000. The one or more pins can provide additional gripbetween the rib bone and the clamp by increasing point contact forcewithout substantially increasing compressive force against the bone.

FIG. 7 illustrates another exemplary embodiment of a clamp for receivingan expandable member. A clamp, as shown in FIG. 7, is similar to theclamp 200 shown in FIG. 5A and FIG. 5B, but, unlike the clamp 200, aclamp 310 shown in FIG. 7 includes a posterior member 318 that includefirst second arms 320, 322 for receiving a posterior portion of the ribbone. The distance between the first and second arms 320, 322 can varyas long as the distance between the first and second arms is sufficientto allow the posterior member of the clamp to be positioned on the ribbone as needed. For example, the distance between the first and secondarms can vary based on the size of the bone to which the clamp issecured. It will be understood that the clamp can encircle the rib bonecompleted when secured thereto, or can go around the rib bone as much asneeded to secure the clamp without encircling the entire bone.

FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, FIG. 8E, FIG. 8F, and FIG. 8Gillustrate another exemplary embodiment of a clamp 410 for receiving anexpandable member that includes a posterior member 418 having a plate410 with a posterior curved portion that is configured for contact witha surface of the rib. The curved portion of the plate 410 include afirst arm 420 and a second arm 422 for receiving a posterior portion ofthe rib bone. An anterior portion of the posterior member 418 includes aring member 412 that extend outwardly from an anterior surface of theposterior portion of the posterior member, and defines an opening 414.The ring member 412 and the opening 414 are sized to receive anexpandable member therein.

The clamp 410 includes an anterior member 416 that is curved and sizedto be positioned around a portion of the posterior member such that afirst end of the anterior member is positioned near the first arm of theposterior member and a second end of the anterior member is positionednear the second arm of the posterior member. The anterior member 416 canbe pivotally coupled to the posterior member 418. In some embodiments,as shown in FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, FIG. 8E, and FIG. 8F,the anterior member is pivotally coupled to the posterior member at apivot point 424 such the first end of the anterior member pivotsrelative to the first arm of the posterior member, as shown in FIG. 8C.The anterior member of the clamp is configured to provide additionalstructure by tightening the individual contact points between the clampand bone, adding stability to the system. This allows all the componentsto be locked in place relative to each other and the bone for a stableand secure structure.

In some embodiments, the clamp 200 can include two cooperatingcomponents, as illustrated in FIG. 9 and FIG. 10. A top (i.e., superior)member 230 is configured to engage and stabilize the rib 1000 (notshown). A bottom (i.e., inferior) member 232 is configured to engage therib 1000 and secure and stabilize the photodynamic support member 102 inplace on the rib 1000. In some embodiments, the bottom member 232 iscurved to avoid the nerves and blood vessels in the proximity of thecoastal groove. In some embodiments, the bottom member 232 includes aportion that is angled inwardly, towards the rib 1000, to apply tensionto the rib 1000 and secure the bottom member 232 to the rib 1000 in acompression fit. In various embodiments, the ring member 212 can bepositioned on the top member 230 or the bottom member 232.

In some embodiments, the top and bottom members 230, 232 are configuredto engage each other and lock together to secure the rib 1000therebetween. Various mechanisms can be used to secure the top andbottom members of the clamp together. In some embodiments, the topmember 230 includes a cam action hinge 242 (see FIG. 9). The cam actionhinge 242 includes a cam bar 244 that is used to modify the compressionon the rib 1000 that is generated by the top member 230. For example,the cam bar 244 is moved towards the main body of the top member 230 toactuate the cam action hinge 242 and ultimately increase the compressiveforce exerted by the top member 230 (or a portion thereof) on the rib1000. The cam action hinge 242 and cam bar 244 are thereby used to lockthe clamp 200 in place on the rib 1000.

In some embodiments, the top and bottom members 230, 232 include sets oflocking serrated teeth 234, 236, respectively, that cooperate to securethe top and bottom members 230, 232 together, as shown in FIG. 10. Insome embodiments, the top some embodiments and bottom members 230, 232include interlocking rails and/or male/female members that secure thetop and bottom members 230, 232 together (not shown).

The top and bottom members 230, 232 are fabricated in multiple sizes, tofacilitate a proper fit onto the rib 1000. For example, the top member230 may be fabricated with different widths (e.g., 5 mm and 8 mm) toaccommodate ribs have varied thickness. In various embodiments, the topand bottom members 230, 232 have a combined height of 10 mm, 11 mm, 12mm, 13 mm or 14 mm to accommodate various heights of ribs. In oneembodiment, the top member 230, or a portion thereof, can have a heightthat is approximately 50% of the height of the rib 1000, to betterstabilize the rib 1000 when engaging same.

In some embodiments, the top and/or bottom members 230, 232 include oneor more bumps, or enlarged endpoints, 238, 240, respectively, as shownin FIGS. 9, 10, and 11A-11B. The bumps 238, 240 assist in engaging therib 1000 and maintaining the top and/or bottom members 230, 232 securelyon the rib 1000. In some embodiments, the top and/or bottom members 230,232 can each have a single bump 238, 240. In some embodiments, the topand/or bottom members 230, 232 can each have multiple bumps (not shown).

A kit for repairing a weakened or fractured bone can also be provided. Akit can include a delivery catheter having an elongated shaft with aproximal end, a distal end, and a longitudinal axis therebetween and oneor more expandable members, such as a balloon, designed to releasablyengage the delivery catheter. One or more clamps can be provided forsecuring the expandable member to a fractured bone, such as a rib. Thekit can also include at least one reinforcing material curable by lightenergy configured to pass through an inner void of the delivery catheterand into the expandable member. The expandable member can be configuredto move from a deflated state to an inflated state when the reinforcingmaterial is added. The reinforcing material can be cured by a lightenergy delivered through the catheter to the expandable member.

As discussed above, some embodiments of the system of the presentdisclosure include two or more of the clamps 200, which are secured atintervals along the length of the rib 1000 (or other bone) having afracture 1100, as illustrated in FIG. 12D, FIG. 12E, FIG. 12F and FIG.12G. After the clamps 200 have been secured to the rib 1000 proximatethe fracture 1100, the expandable member 170 is threaded through theopenings 214 of the ring members 212, as illustrated in FIG. 12G. Itwill be understood that any clamp can be used and secured to the rib toreplace a rib fracture.

FIG. 12A, FIG. 12B, FIG. 12C, FIG. 12D, FIG. 12E, FIG. 12F, FIG. 12G,and FIG. 12H illustrate an embodiment of method steps for repairing afractured rib 1000 using the photodynamic device 102, expandable member170 and any of the clamps, including clamps 200, of the presentdisclosure.

A small incision is made through the skin of the patient's body (notshown), proximate the fractured rib 1000 to be repaired. In someembodiments, an incision can be made following the linear line of therib. As illustrated in FIG. 12A, the tunneling device 300 is introducedthrough the incision and moved between the rib 1000 and the subcutaneouslayer of skin 1200 overlying same to dissect the subcutaneous layer 1200away from the rib 1000 and create a space therebetween. The tunnelingdevice 300 is designed to conform to the curvature of the rib 1000,thereby freeing up the surrounding tissues to expose the intercostalmuscles.

In some embodiments, a guidewire 400 is used to pass the tunnelingdevice 300 along the fractured rib 1000 (see FIG. 12A). In someembodiments, the tunneling device 300 is passed from the posterior sideof a patient to the anterior side of the patient (i.e., from a side ofthe patient's body, under their arm, towards the front of the patient'sbody). In some embodiments, the tunneling device 300 includes anillumination member (not shown) to facilitate visualization of thesurrounding tissues, including the nearby blood vessels (i.e., arteriesand veins).

Depending on the location and pattern of the fracture 1100 on the rib1000, a small skin incision is made anterior the rib 1000 (not shown),and the tunneling device 300 is slightly retracted or withdrawn (e.g., ¾inch). The guidewire 400 can then be removed from the tunneling device300 (see FIG. 12B). The skin incision is opened, for example by using asmall skin retractor (not shown), and a first one of the clamps 200 ispositioned on the rib 1000 (see FIG. 12C).

The clamp 200 is then affixed to the rib 1000, as illustrated in FIG. 5Band FIG. 12C. As discussed above, the top portion 220 of the clamp 200engages the superior surface 1006 of the rib 1000, and the bottomportion 222 engages the costal groove 1010 and inferior surface 1008 ofthe rib 1000. The clamp 200 is secured to the rib 1000 via a compressivefit or interference fit, and tightened into position.

Once the clamp 200 is positioned, the guidewire 400, is directed fromthe incision through the opening 214 of the ring member 212. Theguidewire 400 is used to move and position the expandable member 170along the rib 1000, as further discussed below. The guidewire 400 isattached to a tip of the tunneling device 300, which is then positionedat a point along the rib 1000 where a second one of the clamps 200′ isto be affixed to the rib 1000 (see FIG. 12D). A second small skinincision is made, and the tunneling device 300 is slightly retracted orwithdrawn (e.g., ¾ inch). The guidewire 400 can then be removed from thetunneling device 300. The second skin incision is opened, and the secondclamp 200′ is positioned on and affixed to the rib 1000. The guidewire400 is directed from the second incision through the opening 214 of thering member 212 of the second clamp 200′ (see FIG. 12D). It will beunderstood that the guidewire is passed through each of the clampspositioned on the rib bone.

In some embodiments of the system, as in the case of small fractures,only two clamps 200, 200′ are required—one clamp on each side of thefracture. More severe fractures require at least four clamps (e.g., twoor more clamps on either side of the fracture) to provide adequatesupport.

In an embodiment having at least four of the clamps 200, the guidewire400 is then attached to a tip of the tunneling device 300, which is thenpositioned at a point along the rib 1000 where a third one of the clamps200″ is to be affixed to the rib 1000 (see FIG. 12D). A third small skinincision is made, and the tunneling device 300 is slightly retracted orwithdrawn (e.g., ¾ inch). The guidewire 400 may then be removed from thetunneling device 300. The third skin incision is opened, and the thirdclamp 200″ is positioned on and affixed to the rib 1000. The guidewire400 is then directed from the third incision through the opening 214 ofthe ring member 212 of the third clamp 200″. This procedure is repeatedto affix each additional clamp (e.g., a fourth clamp 200′) to the rib1000 (see FIG. 12E).

Once the required number of clamps 200 are affixed to the rib 1000, thetunneling device 300 is removed, and the guidewire 400 running from thefirst clamp 200 to the last clamp (the clamp 200′″ in FIG. 12E) throughthe respective ring members 212/openings 214 is removed from thetunneling device 300 and left in place.

As illustrated in FIG. 12F, a sheath 500 and dilator 600 are thendelivered over the guidewire 400 and directed in place through each ofthe respective ring members 212/openings 214 of the clamps 200. Thedilator 600 and guidewire 400 are then removed, and the sheath 500 isleft in place through the respective ring members 212/openings 214 alongthe rib 1000.

The expandable member 170 is then introduced into the sheath 500 alongthe guidewire 400, such that the expandable member 170 extends throughthe respective ring members 212/openings 214 along the rib 1000 withinthe sheath 500, as illustrated in FIG. 12G. In this embodiment, thedelivery catheter 150 is connected to the expandable member 170 at thedistal end of the expandable member 170. The sheath 500 is then removed(i.e., torn away), along with the guidewire 400, and the expandablemember 170 is inflated with the liquid monomer (i.e., thelight-sensitive liquid 165). As explained above, the light-sensitiveliquid 165 is infused through the inner void in the delivery catheter150 into the expandable member 170 to move the expandable member from adeflated state to an inflated state. The expandable member 170 assumesthe shape and span/curvature of the rib 1000, and is cured in place (seeFIG. 12H). More particularly, once the position of the expandable member170 on the rib 1000 is confirmed, the light-sensitive liquid 165 may behardened within the expandable member 170, such as by illumination witha visible emitting light source (not shown), to form the photodynamicsupport member 102 (see FIG. 12H), thereby providing longitudinal androtational stability to the rib 1000. After the light-sensitive liquidhas been hardened, the light source may be removed from the device.Alternatively, the light source can remain in the expandable member 170to provide increased rigidity. The photodynamic support member 102 canthen be released from the delivery catheter 150 by any known methods inthe art.

In some embodiments, a larger incision can be used to expose one or moreribs and place one or more clamps thereon. This can be used insituations involving the fracture of multiple ribs, or when more thanone fracture has occurred at various locations on one or more ribs.

In some embodiments, one or more clamps can be preplaced on thetunneling device. The tunneling device can be passed from the posteriorside of a patient to the anterior side of the patient (i.e., deliveredfrom the proximal aspect to the distal aspect of the patient) with theclamps removably attached thereto. The clamps can be applied to the ribas the tunneling device is pulled back from the distal aspect to theproximal aspect. Thus, after an incision is made, the clamp is attachedto the rib starting at the distal-most clamp on the tunneling device. Asecond incision can be made to place the next clamp, and this can berepeated until all the clamps on the tunneling device are placed on thefractured bone.

In some embodiments, the photodynamic support member 102 can be formedwith a plurality of expandable members, as shown in FIG. 13A and FIG.13B, where each expandable member 330 can be inflated or deflatedindependently of other expandable members. The individual expandablemembers can be inflated or deflated as desired to adjust the position,angulation, alignment or combinations thereof of photodynamic supportmember 102. In some embodiments, the use of more than one expandablemember can increase the granularity of the adjustment of the supportmember relative to the fractured bone. It will be understood that anynumber of expandable members can be used, and that the one or moreclamps through which the expandable members extend can be adjusted insize and/or shape to accommodate the one or more expandable members.

In some embodiments, the diameter of an expandable member, such as theexpandable member 170 or the multiple expandable members 330 (FIG. 13A),is slighter larger than the diameter of the openings 214 of the ringmembers 212, such that the expandable member will be locked into placewithin the openings 214/ring members 212, once it is expanded by theliquid monomer.

In some embodiments, the diameter of an expandable member, such as theexpandable member 170, is slightly smaller than the diameter of theopenings 214, and caps (not shown) are placed on the ends of theexpandable member 170 to immobilize it within clamps, such as the clamps200.

In some embodiments, an expandable member, such as the expandable member170, functions as part of a compressive locking mechanism for a clamp,such as the clamps 200. The compressive locking mechanism for each clamp200 includes a handle (not shown) that engages the rib 1000 in aclosed/locked position by the presence of the expandable member 170within the openings 214 of the ring members 212. The handle/compressivelocking mechanism can only be changed to an open/unlocked position(disengaging/releasing the rib 1000) when the expandable member 170 isremoved from the openings 214 of the ring members 212.

In some embodiments, the support member 102 is not photodynamic, but isformed as a metal rod (e.g., titanium or stainless steel) that isdimensioned to be secured along the bone to be repaired in the same or asimilar manner as disclosed herein for the photodynamic support member102. In some embodiments, a compressible two-member assembly is used tohold the metal rod/support member in place along the rib or other bone.The two-member assembly can include two plates that sandwich the metalrod/support member therebetween. The ring members of the clamps aresized to receive the metal rod in these embodiments. Each ring membercan include an end cap that covers the end of the metal rod. The cap isin the same plane (i.e., coplanar with) as the rib, and can be securedto the plate/base of the clamp.

Although the system is described in connection with the stabilizationand repair of a fractured rib, the system and methods of the presentdisclosure can also be used in the external fixation in the repair ofother fractured bones, including, without limitation, the femur, tibia,hips and fibula of the legs, the humerus, radius and ulna of the arms,metacarpal and metatarsal bones of the hands and feet, the phalanges ofthe fingers and toes, the clavicle, ankle, wrist, mandible, spinalarticular surface bones including, but not limited to, the facet jointand the vertebral body, ribs, temporomandibular joint, and pelvis.

The system of the present disclosure can be utilized in the externalfixation of a bone without requiring a rod or other member to be placedwithin the intramedullary canal.

The system of the present disclosure enables external fixation (e.g., abone plate or rod) without the need to use screws to secure the externalplate or rod to the bone. These screws penetrate and violate/damage thecortex of the bone. In contrast, the system of the present disclosureprovides a rigid bar (or plate) that conforms to the external shape ofthe bone and is removably secured to the bone at multiple points withminimal contact.

As discussed above in connection with the rib fixation system, theexternal fixation system includes subcutaneous fixator componentssecured between the injured bone and the adjacent skin. The system isfor temporary external fixation of an injured bone.

In some embodiments, the external fixation system can involve rods orother members that are secured to the injured bone via screws or otherforms of fixation. The rods may have a variety of lengths, dependingupon indication and fracture pattern. In various embodiments, the rodshave lengths of 100 mm, 150 mm, 200 mm, 250 mm, 300 mm, 350 mm, 400 mmor 450 mm. The rods can be made either longer or shorter, depending onvarious factors, including the specific indications, the location of thefracture and the type of fracture. It can be possible to use thisfixation system in cooperation with the bone stabilization system havingone or more expandable members as described above.

In some embodiments, the rods are threaded (i.e., screw posts or Shantzscrews) that are driven into the bone at an ostensibly 90 degree angleto the longitudinal plane of the bone. These rods are deliveredpercutaneously into the bone, and terminate (i.e., have a terminalportion/end) that extends/rises above the skin surface (i.e., a planedefined by the skin surface) by some pre-determined distance (i.e.,height). This distance/height depends on indication, and, in variousembodiments, this distance/height is 20 mm, 30 mm, 40 mm, 50 mm, 60 mm,70 mm, 80 mm, 90 mm or 100 mm. Larger bones and transiting jointsrequire larger distances/heights.

Multiple rods are delivered into the bone at points on either side ofthe fracture. The individual rods are then connected by connection rods,thereby fixing and stabilizing the span of bone along which theconnection rods extend. Some embodiments of the rods also includefixation fittings, which are a form of capture device located on theterminal portions/ends of the rods so as to secure the rods/screw poststo the connection rods.

The use of a flexible connection member that becomes rigid according tothis embodiment resolves/eliminates such alignment issues.

Circular attachments (e.g., rings) are provided proximate the rods forreceiving an expandable member that may be formed into a rigid rod bycuring, as discussed above in connection with the rib fixation system.The circular attachments/rings may be a circular capture device havingtwo semi-circular “half c's” or other curved shapes and an innercompression screw or other means for capturing the inflatable rod.

Use of the expandable member in external fixation would enable complexshapes and alignments to be obtained by moving the position of theexpandable member to the fixation rods attached to the bone. This systemat least partially eliminates the difficulties presented by thealignment of rigid fixation members in a conventional external fixationsystem.

While the presently disclosed embodiments have been described withreference to certain embodiments thereof, it should be understood bythose skilled in the art that various changes may be made andequivalents may be substituted without departing from the true spiritand scope of the presently disclosed embodiments. In addition, manymodifications may be made to adapt to a particular situation,indication, material and composition of matter, process step or steps,without departing from the spirit and scope of the present presentlydisclosed embodiments.

What is claimed is:
 1. A bone fixation device comprising: an expandablemember capable of moving from a deflated state to an inflated state byinfusing at least one curable material into the expandable member, theat least one curable material being configured to be cured within theexpandable member to harden the expandable member; and one or moreclamps configured to engage a rib bone and receive the expandable membersuch that the one or more clamps secure the expandable member to the ribbone, wherein the expandable member is configured to be adjustable toconform to a shape of a rib bone with the at least one curable material.2. The bone fixation device of claim 1, further comprising a deliverycatheter having an elongated shaft with a proximal end, a distal end,and a longitudinal axis therebetween, the expandable member beingreleasably engaged with the distal end of the delivery catheter.
 3. Thebone fixation device of claim 1, wherein the one or more clamps includea posterior member and an anterior member.
 4. The bone fixation deviceof claim 3, wherein the posterior member and the anterior member aremovably connected to one another between an open position such that theone or more clamps are configured to be positioned on the rib bone and aclosed positioned such that the one or more clamps are configured tosecure to at least a portion of the rib bone.
 5. The bone fixationdevice of claim 1, wherein the one or more clamps are shaped to receivethe rib bone such that the one or more clamps extend around at least aportion of the rib bone.
 6. The bone fixation device of claim 5, whereinthe one or more clamps include a posterior member and an anteriormember, and the posterior member includes first and second armsconfigured to extend around a portion of a posterior side of the ribbone to secure the one or more clamps thereto.
 7. The bone fixationdevice of claim 1, wherein the one or more clamps include at least onecontact point on a surface of the one or more clamps that is configuredto contact the rib bone such that the at least one contact point isconfigured to increase a grip of the one or more clamps on the rib bone.8. The bone fixation device of claim 1, wherein the one or more clampsincludes first and second clamps configured to be positioned on eitherside of a fracture in the rib bone.
 9. The bone fixation device of claim1, wherein the expandable member is adjustable to conform to the shapeof the rib bone to allow for a correct orientation of the rib bone. 10.The bone fixation device of claim 1, wherein the at least one curablematerial is curable by light energy.
 11. A bone fixation devicecomprising: an expandable member releasably engaging a distal end of adelivery catheter having an inner lumen extending therethrough; one ormore clamps configured to engage a rib bone and receive the expandablemember such that the one or more clamps secure the expandable member tothe rib bone; and at least one curable material; wherein the expandablemember is configured to move from a deflated state to an inflated statewhen the at least one curable material is added into the expandablemember to allow for a correct orientation of a rib bone, and wherein theat least one curable material is curable inside the expandable member toharden the expandable member.
 12. The bone fixation device of claim 11,wherein the one or more clamps include a posterior member and ananterior member.
 13. The bone fixation device of claim 12, wherein theposterior member and the anterior member are movably connected to oneanother between an open position such that the one or more clamps areconfigured to be positioned on the rib bone and a closed positioned suchthat the one or more clamps are configured to secure to at least aportion of the rib bone.
 14. The bone fixation device of claim 11,wherein the one or more clamps are shaped to receive the rib bone suchthat the one or more clamps extend around at least a portion of the ribbone.
 15. The bone fixation device of claim 11, wherein the one or moreclamps include at least one contact point on a surface of the one ormore clamps that is configured to contact the rib bone such that the atleast one contact point is configured to increase a grip of the one ormore clamps on the rib bone.
 16. The bone fixation device of claim 11,wherein expandable member is configured to be adjustable to allow theexpandable member to conform to a shape of the rib bone with the atleast one curable material.
 17. The bone fixation device of claim 11,wherein the one or more clamps includes first and second clampsconfigured to be positioned on either side of a fracture in the ribbone.
 18. The bone fixation device of claim 11 further comprising alight fiber extending through the inner lumen into the expandable memberto emit a light energy into the expandable member, wherein the at leastone curable material is curable by the light energy emitted from thelight fiber.
 19. A method of repairing a fractured bone, comprising:positioning one or more clamps on a rib bone, the one or more clampsincluding an opening configured to receive a portion of an expandablemember therethrough to secure the expandable member to the rib bone;passing the expandable member releasably engaging a delivery catheterthrough the opening of the one or more clamps, wherein the deliverycatheter has an inner void for passing of one or more curable materialto the expandable member; expanding the expandable member by deliveringat least one curable material through the delivery catheter and into theexpandable member; and adjusting the expandable member by altering anamount of the at least one curable material therein to allow for correctorientation of the rib bone.